Thermo Scientific HyClone Single-Use Mixer (S.U.M.) 500 L

Transcription

1 Thermo Scientific HyClone Single-Use Mixer (S.U.M.) 500 L The Thermo Scientific HyClone Single-Use Mixer (S.U.M.) is part of a product family which provides efficient and powerful mixing based on a conventional stirred tank design for a wide range of applications. For use with powder rehydration for preparation of critical sterile solutions and suspensions. The current range includes units with maximum volumes of 200, 500 and 1000 L. Data Sheet 057 Rev 1 Overview: The Single-Use Mixer is based on the same concept as the Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) with a single-use BioProcess Container (BPC ), an integrated impeller and a reusable hardware system providing support, mobility, mixing motor and control system. The range of product solutions included in this data sheet expand the functionality offered by the original S.U.M. products described in data sheet 033. These include: Stainless Steel Hardware Systems With or without heating/cooling jacket Cutout sections to facilitate S.U.M. BPC loading and monitoring probe capability Location mechanism for S.U.M. BPC S.U.M. BPC Options Open top liner media/buffer preparation Closed BPC with powder port for contained media/buffer preparation Closed BPC with powder port and monitoring probe capability Closed BPC for liquid-liquid mixing of critical sterile solutions such as pooling of fractions or processing intermediate solutions Closed BPC for liquid-liquid mixing with monitoring probe capability 500 L S.U.M. Item Rated Liquid Working Volume Minimum Liquid Working Volume BPC Chamber Diameter BPC Chamber Shoulder Height Liquid Rated Working Volume 500 L Non-Heated 500 L 100 L (75.6 cm) 57.5 (146 cm) 44 (111.8 cm) Overall Geometry (height/diameter ratio) 1.5:1 Fluid Working Volume (height/diameter) Ratio 1.7:1 (quantity x blade count) 1 x 3 Diameter Hold-Up Volume (typical) Electrical Power Supply Requirement (voltage, phase, amp) Skid Width Skid Depth Skid Height (20 cm) <100 ml 500 L Water Jacket Heater 120 VAC, single, 15 Amp Non GFCI circuit 33.6 (85.3 cm) 52 (132 cm) 77 (195.6 cm) Dry Skid Weight (mass) 707 lbs (321 kg) 734 lbs (333 kg) Wet Skid Weight Rated Working Volume (mass) Minimum Ceiling Height Recommended 1809 lbs (821 kg) 11 ( 335cm) 1836 lbs (833 kg)

2 Powder-Liquid Applications Part number SH For use with tubing welder (CPC Quick Connect and/or Tri-clamp End Treatments) 4. Powder Addition Port 2. Addition Line 1. Bottom Drain 3. Recirculation/Sample Line 1 Bottom Drain 1/2" (12.7 mm) ID X 3/4" (19.1 mm) OD C-Flex X 48" (122 cm) 2 Addition Line 1/2" (12.7 mm) ID X 5/8" (15.9 mm) OD C-Flex X 60" (152 cm) 3 Recirculation/Sample Line 4 Powder Addition Port 3" (76 mm) Sanitary Fitting, Tri-clamp Cap with gasket Liquid-Liquid Applications Part number SH For use with tubing welder (CPC Quick Connect and/or Tri-clamp End Treatments) 4. Recirculation/Sample Line 1. Bottom Drain 2. Fill Line 3. Vent Filter 5. Additional Line 1 Bottom Drain 1/2" (12.7 mm) ID X 3/4" (19.1 mm) OD C-Flex X 48" (122 cm) 2 Fill Line 3/4" (19.1 mm) ID X 1" (25.4 mm) OD C-Flex X 60" (152 cm) 3 Vent Filter 1/4" (6.4 mm) ID X 1/2" (12.7 mm) OD C-Flex X 4" (10.2 cm) 4 Recirculation/Sample Line 1 1/2" (38.1 mm) Tri-clamp SterilEnz Sterile Hydrophobic Vent Filter (0.2 micron PVDF - Pall Acro 50) 5 Addition Line 3/8" (9.5 mm) ID X 5/8" (15.9 mm) OD C-Flex X 24" (61 cm) Plugged 3/8" (9.5 mm) MPX body 2

3 Powder-Liquid Applications with Probe Ports and Thermo-well Part number SH For use with tubing welder (CPC Quick Connect or Tri-clamp End Treatments) 8. Powder Addition Port 2. Additional Line 3-4. Probe Ports (2) 5. Unused 1. Recirculation/Sample Line 1 Recirculation/Sample line 2 Addition Line 1/2" (12.7 mm) ID X 5/8" (15.9 mm) OD C-Flex X 60" (152 cm) 3-4 Probe Ports (2) None Pall Kleenpak Aseptic Connector KPCHT Series (Female) 5 Unused None Plug 6 Thermo-well/ Small Volume Sample Thermo-well Adapter for 1/8" (3.2 mm) Diameter 1/8" (3.2 mm) ID X 1/4" (6.4 mm) OD C-Flex X 12" (30 cm) 6. Thermo-well/Small Volume Sample 7. Bottom Drain Luer and SmartSite Valve Port 7 Bottom Drain 1/2" (12.7 mm) ID X 3/4" (19.1 mm) OD C-Flex X 48" (122 cm) 8 Powder Addition Port 3" (76 mm) Sanitary Fitting, Tri-clamp Cap with gasket Liquid-Liquid Applications with Probe Ports and Thermo-well Part number SH For use with tubing welder (CPC Quick Connect or Tri-clamp End Treatments) 6. Recirculation/Sample Line 7. Fill Line 3-4. Probe Ports (2) 3. Unused 5. Vent Filter 6. Additional Line 4. Thermo-well/Small Volume Sample 1-2 Probe Ports (2) None Pall Kleenpak Aseptic Connector KPCHT Series (Female) 3 Unused None Plug 4 Thermo-well/ Small Volume Sample Thermo-well Adapter for 1/8" (3.2 mm) Diameter 1/8" (3.2 mm) ID X 1/4" (6.4 mm) OD C-Flex X 12" (30 cm) Luer and SmartSite Valve Port 5 Bottom Drain 1/2" (12.7 mm) ID X 3/4" (19.1 mm) OD C-Flex X 48" (122 cm) Capped 1/2" (1.27 cm) MPX insert 6 Recirculation/Sample line 7 Fill Line 3/4" (19.1 mm) ID X 1" (25.4 mm) OD C-Flex X 60" (152 cm) 1 1/2" Tri-clamp SterilEnz 8 Vent Filter 1/4" (6.4 mm) ID X 1/2" (12.7 mm) OD C-Flex X 4" (10.2 cm) 5. Bottom Drain Sterile Hydrophobic Vent Filter (0.2 micron PVDF - Pall Acro 50) 9 Addition Line 3/8" (9.5 mm) ID X 5/8" (15.9 mm) OD C-Flex X 24" (61 cm) Plugged 3/8" (9.5 mm) MPX body 3

4 Ordering Information for Standard Products Autoclave Tray and Probe Kits: Probe Assembly Probe Handle Autoclave Tray KPC Connector Additional Information on Autoclave Tray: Fabricated from stainless steel Plastic carry handle for easy transport right out of the autoclave Positions probes on 15% incline for greater probe/membrane longevity Will restrain probe bellows from collapsing during sterilization Probe holder accommodates two probes Powdertainer Hanger: The Single-Use Mixer (S.U.M.) can be equipped with a Thermo Scientific HyClone Powdertainer hanger if so desired. When adding solids to liquids, this optional feature enables utilization of the Powdertainer powder feed system. The Powdertainer hanger can be used to support full 1, 5 or 25 Kg Powdertainers and positions the 3 sanitary connectors for bag to bag connection and solids transfer. Adjustable from 20 to 36 Bag Hanger Open-Top Mixing (OTM) use: The S.U.M. can be equipped with a motor sleeve accessory to enable use of open top liners and single-use impeller sleeves. The OTM option is a non-sterile easy-to-use mixing option. The motor sleeve in the S.U.M. may be replaced with the OTM sleeve if desired. This will allow the use of a single-use liner and a single-use impeller sleeve which is attached to the motor sleeve with a quick connect. The drive shaft may then be inserted into the sleeve for mixing. Motor Sleeve Bottom Drain Probe Shelf: The S.U.M. can be equipped with a probe shelf for probe support and retention. Bag Support Collar Single-use Liner Single-use Sleeve Accessories: Part Number SH Probe Assembly (non-sterile) Used to package probes (not supplied) for sterilization and to aseptically connect them to the S.U.M. BPC. SV SV SV Heavy Duty Tubing Clamp Heavy Duty Tubing Clamp (4 pack of SV ) Heavy Duty Tubing Clamp (10 pack of SV ) Reusable tubing clamp used on probe ports when connecting probe assembly. SV S.U.M. thermo-well/sample port Used for RTD calibration/validation. SV RTD Pt100 Resistance Temperature Detector for use with S.U.M BPC thermo-well/sampling port. SV Autoclave Tray for Probe Kits (stainless steel) Support tray which allows the probes to be safely autoclaved. SH SH Sterile Sampling Manifold with luer lock (individual) Sterile Sampling Manifold with luer lock (10 pack) Available for aseptic luer connection or welding onto the sample line to take sample sets. SV50193 Load Cells* Installed by manufacturer or end-user SV Probe Shelf Support shelf for use with probe assemblies. SV Powdertainer Hanger with Support Collar To support BPCs during Powdertainer attachment SV Open-Top Motor Sleeve Required for use with single-use impeller sleeve SH Single-use Liner SH Single-use Sleeve For Open-Top Mixing * For more information on Load Cells refer to Data Sheet 048. Bottom drain liner with 72 (182.9 cm) of ½ (12.7 mm) C-Flex tubing and an MPX insert connector, CX3-9 Film 4

5 Hardware Standard Products Non-Heated: Part Number SV L S.U.M., 120 VAC, Single Phase Includes: 304 stainless steel outer support container with swivel SV L S.U.M., 240 VAC, Single Phase caster platform, variable speed agitation controller, motor, drive assembly with shaft and standard tool set Water Jacket: Part Number SV SV L S.U.M., 120 VAC, Single Phase 500 L S.U.M., 240 VAC, Single Phase Includes: 304 stainless steel outer support container with swivel caster platform, variable speed agitation controller, motor, drive assembly with shaft, integrated water jacket and standard tool set Custom Hardware Options: For stainless steel capabilities, refer to the Stainless Steel Hardware Capabilities Data Sheet 054. Custom BPC Options: Tubing Type C-Flex (clear, white, and ADCF), Silicone, PVC, PharMed or PharmaPure Tubing Size Connectors Specific Lengths of 1/8 to 1 (3.18 to 25.4 mm) ID depending on type of tubing chosen Luer 1/8 to 1/2 (3.18 to 12.7 mm) ID CPC 1/4 to 3/4 (6.35 to 19 mm) ID SIP Connector 1/4 to 3/4 (6.35 to 19 mm) ID Tri-clamp 1/8 to 1 (3.18 to 25.4mm) ID Mini-Tri-clamp 1/8 to 1/2 (6.35 to 12.7 mm) ID Aseptic Connection Device All available sizes of Pall Kleenpak and BioQuate DAC Others Needle-free sample port (SmartSite or Clave ) Filter Capsule (Millipore, Pall, Sartorius, Domnick Hunter, Meissner, Other) Please Note: Not all options are available for all ports. Customization of port type and location, chamber dimensions or mixing assembly is not available. For additional information, please refer to the Selection Guides in the 2008 BPC Catalog. Presentation (as dry BPC systems): Outer Packaging Label Sterilization Shipping Container Documentation Supplied flat-packed Two polyethylene outer layers Product code Lot number Expiry date on outer packaging and shipping container Irradiation (25 to 38 kgy) inside outer packaging Durable cardboard carton Certificate of Analysis provided with each lot for each delivery 5

6 Hardware Features 500 L S.U.M.: The stainless steel outer support container contains the following features: 1. Mixer motor 2. Bearing port receiver with clamp 3. Drive shaft 4. Mixing assembly with shield 5. Liquid sight window 6. Standard tool set 7. Powdertainer Hanger Mount 8. Stainless steel (304) outer support container 9. Control panel 10. Platform with large diameter wheels 11. Bottom cut outs for BPC alignment 12. Probe Access Door 13. Stretch Hooks L with Water Jacket: The stainless steel outer support container contains the following features: 1. Mixer motor 2. Bearing port receiver with clamp 3. Drive shaft 4. Mixing assembly with shield 5. Liquid sight window 6. Standard tool set (not shown) 7. Water Jacket 8. Stainless steel (304) outer support container 9. Control panel 10. Platform with large diameter wheels 11. Bottom cut outs for BPC alignment 12. Probe access door 13. Jacket quick connect couplings 14. Powdertainer Hanger Mount 15. Stretch Hooks

7 Data Sheet Outer Support Container (units in inches [mm]) 500 L S.U.M.: 500 L S.U.M. Jacket: 2008 Thermo Fisher Scientific Inc. All rights reserved. CPC is a registered trademark of Colder Product Company. SterilEnz is a registered trademark of PAW BioScience Products. SmartSite is a trademark of ALARIS Medical Systems, Inc. C-Flex and PharMed are registered trademarks of Saint-Gobain. PharmaPure is a registered trademark of PharmaPure Tubing. Clave is a registered trademark of ICU Medical. Pall TM and Kleenpak are registered trademarks of Pall Corporation. BioQuate is a registered trademark of BioQuate Incorporated. Millipore is a registered trademark of Millipore Corporation. Meissner is a registered trademark of Meissner Filtration Products. Domnick Hunter is a registered trademark of Parker Hannifin Ltd. Sartorius TM is a registered trademark of Sartorius Stedim Biotech. All other trademarks, registered trademarks, or logos are properties of their respective owners. Specifications, terms and pricing are subject to change. Not all products are available in all countries. Please consult your local sales representative for details. HyClone Laboratories, Inc. Logan, UT USA is ISO Certified. HyClone - Media BPC Sera 925 West 1800 South Logan, UT In Americas/Asia fax In Europe fax